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HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer

NCT01387932 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2021-11-30

Study results available
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Summary

The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.

Conditions

Interventions

DEVICE

HepaSphere/QuadraSphere Microspheres

HepaSphere/QuadraSphere Microspheres loaded with doxorubicin

PROCEDURE

PVA, lipiodol, doxorubicin

Conventional TACE procedure using PVA, lipiodol and doxorubicin

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Soulen, MD · University of Pennsylvania

  • Riccardo Lencioni, MD · Independent Radiology Panel

  • Josep Llovet, MD · Data Safety Monitoring Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2021-02-28
Completion
2021-02-28
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Greece
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01387932 on ClinicalTrials.gov